Degarelix Before Radical Prostatectomy
A Study of the Early Biological Effects of Testosterone Suppression in Prostate Cancer Using Neoadjuvant Degarelix Prior to Radical Prostatectomy
1 other identifier
interventional
40
1 country
1
Brief Summary
The biological effects of castration on prostate cancers will be studies by administration of degarelix prior to radical prostatectomy. The effects will be studied by analysis of gene expression and immunohistochemistry focusing on markers of proliferation and apoptosis of samples taken at the time of radical prostatectomy (7 days after administration of degarelix). Tumours from patients treated with neo-adjuvant degarelix will be compared with tumours from patients who have not been medically castrated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 prostate-cancer
Started Jul 2011
Typical duration for early_phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 6, 2013
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 16, 2014
December 1, 2014
4 years
May 6, 2013
December 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proliferative index defined by immunohistochemistry for ki67
at surgery, 7 days after administration of degarelix
Secondary Outcomes (1)
Gene expression levels measured by microarray
At surgery 7 days after degarelix administration
Study Arms (1)
Degarelix treated group
EXPERIMENTAL240mg degarelix s.c. injection to be administered 7 days prior to radical prostatectomy for high/intermediate risk prostate cancer.
Interventions
7 days prior to radical prostatectomy the patient will have a subcutaneous injection of 240mg degarelix.
Eligibility Criteria
You may qualify if:
- Intermediate/high risk prostate cancer
- Patient eligible for and wanting surgery
You may not qualify if:
- Inability to consent
- Previous thromboembolism/arrhythmias
- contraindication to degarelix or surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cambridge University Hopital NHS Trust
Cambridge, Cambridgeshire, CB20QQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Neal, BSc MS FRCS
Cambridge University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Lecturer in Urology
Study Record Dates
First Submitted
May 6, 2013
First Posted
May 14, 2013
Study Start
July 1, 2011
Primary Completion
July 1, 2015
Study Completion
December 1, 2015
Last Updated
December 16, 2014
Record last verified: 2014-12